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Table 2 Incidence of overall per dose grade 3 solicited symptoms reported within 4 days post-vaccination and of grade 3 unsolicited symptoms reported within 31 days post-vaccination (total vaccinated cohort)

From: Safety and reactogenicity of primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in Vietnamese infants: a randomised, controlled trial

 

PHiD-CV group N=583/585*

Control group N=297

Grade 3 Symptom

n

% [95% CI]

n

% [95% CI]

Any symptom

48

8.2 [6.1, 10.8]

9

3.0 [1.4, 5.7]

Local symptom

43

7.4 [5.4, 9.8]

6

2.0 [0.7, 4.3]

Pain

38

6.5 [4.7, 8.8]

3

1.0 [0.2, 2.9]

Redness

5

0.9 [0.3, 2.0]

1

0.3 [0.0, 1.9]

Swelling

7

1.2 [0.5, 2.5]

2

0.7 [0.1, 2.4]

General symptom

13

2.2 [1.2, 3.8]

3

1.0 [0.2, 2.9]

Drowsiness

3

0.5 [0.1, 1.5]

0

0.0 [0.0, 1.2]

Fever

0

0.0 [0.0, 0.6]

1

0.3 [0.0, 1.9]

Irritability

11

1.9 [0.9, 3.4]

1

0.3 [0.0, 1.9]

Loss of appetite

0

0.0 [0.0, 0.6]

0

0.0 [0.0, 1.2]

Unsolicited symptom

2

0.3 [0.0, 1.2]

1

0.3 [0.0, 1.9]

  1. PHiD-CV group= infants vaccinated with PHiD-CV co-administered with DTPa-HBV-IPV/Hib at 2, 3, and 4 months of age; Control group= infants vaccinated with DTPa-HBV-IPV/Hib at 2, 3, and 4 months of age; N= number of doses; *= number of administered doses for unsolicited symptom; n= number of reported symptoms; %= percentage of doses followed by the specified symptom with grade 3 intensity; 95% CI= 95% confidence interval.